AMERLEX HUMAN PLACENTAL LACTOGEN

Radioimmunoassay, Human Placental Lactogen

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex Human Placental Lactogen.

Pre-market Notification Details

Device IDK840588
510k NumberK840588
Device Name:AMERLEX HUMAN PLACENTAL LACTOGEN
ClassificationRadioimmunoassay, Human Placental Lactogen
Applicant AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJMF  
CFR Regulation Number862.1585 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-09
Decision Date1984-04-04

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